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Hamburg, Germany

Combe B.,Montpellier University | Dasgupta B.,University of the Sea | Louw I.,Panorama Medical Center | Pal S.,Advance Rheumatology Clinic | And 7 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: To evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite diseasemodifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission. Methods: GO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received addon monthly 50-mg subcutaneous golimumab for 6 months. The percentage of patients with good/ moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)- erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28-ESR remission was measured. Results: 3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6 years and mean DAS28-ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/ moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (∼25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population. Conclusions: Add-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen. Source


Hauert J.,Klinik Dr. Guth | Loose D.A.,Facharztklinik Hamburg | Dreyer T.,Universitatsklinikum Giessen | Obermayer B.,Schon Klinik Hamburg Eilbek | Deibele A.,Klinik Dr. Guth
Orthopade | Year: 2012

Patients with congenital vascular malformations often suffer from arthralgia, especially of the lower limbs. This orthopaedic disease pattern is defined as destructive, angiodysplatic arthritis or Hauert disease and leads to very early destruction of the joints. By presenting diagnostic and therapeutic algorithms, Hauert disease is emphasized as a possible differential diagnosis in order to minimize the risk of an incorrect diagnosis which might lead to under-, over-, or even incorrect treatment. A minimally invasive transathroscopic therapy in the early stages can lead to significant improvement of symptoms and prevention of progressive joint destruction. © Springer-Verlag 2012. Source


McInnes I.B.,University of Glasgow | Sieper J.,Rheumatology | Braun J.,Rheumazentrum Ruhrgebiet | Emery P.,University of Leeds | And 12 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objective: To evaluate the efficacy and safety of secukinumab, a fully human, anti-interleukin (IL)-17A monoclonal antibody, in patients with psoriatic arthritis (PsA). Methods: 42 patients with active PsA fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria were randomly assigned (2:1) to receive two intravenous secukinumab doses (10 mg/kg; n=28) or placebo (n=14) 3 weeks apart. The primary endpoint was the proportion of American College of Rheumatology (ACR) 20 responses at week 6 for secukinumab versus placebo (one-sided p<0.1). Results: Primary endpoint: ACR20 responses at week 6 were 39% (9/23) for secukinumab versus 23% (3/13) for placebo (p=0.27). ACR20 responses were greater with secukinumab versus placebo at week 12 (39% (9/23) vs 15% (2/13), p=0.13) and week 24 (43% (10/23) vs 18% (2/11), p= 0.14). At week 6, 'good' European League Against Rheumatism response was seen in 21.7% (5/23) secukinumab versus 9.1% (1/11) placebo patients. Compared with placebo at week 6, significant reductions were observed among secukinumab recipients for C reactive protein (p=0.039), erythrocyte sedimentation rate (p=0.038), Health Assessment Questionnaire Disability Index (p=0.002) and Short Form Health Survey (SF-36; p=0.030) scores. The overall adverse event (AE) frequency was comparable between secukinumab (26 (93%)) and placebo (11 (79%)) recipients. Six serious AEs (SAEs) were reported in four secukinumab patients and one SAE in one placebo patient. Conclusions: Although the primary endpoint was not met, clinical responses, acute-phase reactant and quality of life improvements were greater with secukinumab versus placebo, suggesting some clinical benefit. Secukinumab exhibited satisfactory safety. Larger clinical trials of secukinumab in PsA are warranted. Source


Harter M.,University of Hamburg | Kentgens M.,Gesundheitswirtschaft Hamburg GmbH | Brandes A.,Gesundheitswirtschaft Hamburg GmbH | Dirmaier J.,University of Hamburg | And 8 more authors.
European Archives of Psychiatry and Clinical Neuroscience | Year: 2012

With the public-funded research and development project psychenet: the Hamburg Network for Mental Health (2011-2014), the Federal Ministry of Education and Research contributes to strengthening healthcare regions in Germany by establishing new trans-sectoral cooperations and implement and evaluate selected innovations. More than 60 partners from research, health care, health industry and government in the Free and Hanseatic City of Hamburg are promoting innovative measures to improve the treatment for mental disorders. The main objective is to implement integrated healthcare networks based on evidence for effective treatment methods, deriving from high-quality research throughout five indications such as psychosis, depression, somatoform and functional syndromes, anorexia and bulimia and addiction illnesses in adolescence. Those networks are accompanied by additional measures, for example, for improving information and education, addressing occupational health or strengthening the participation of patients and their families suffering from mental illness. © 2012 Springer-Verlag. Source


Kavanaugh A.,University of California at San Diego | Mease P.J.,Swedish Medical Center | Gomez-Reino J.J.,Hospital Clinico Universitario | Adebajo A.O.,University of Sheffield | And 9 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: Apremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy. Methods: In the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20% improvement in modified American College of Rheumatology response criteria (ACR20) at week 16. Results: At week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed. Conclusions: Apremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated. Source

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